Axium PrimeTM FC-6-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536034228), received between Aug 24, 2021 and Aug 24, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT AN AXIUM FRAMING COIL DETACHED PREMATURELY DURING A PROCEDURE TO TREAT AN ANEURYSM. THE COIL WAS REMOVED WITH THE CATHETER. IT WAS NOTED THAT THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT OBSERVED TO BE BENT OR BROKEN. THERE WAS NO FRICTION OR OTHER DIFFICULTY NOTED DURING DELIVERY OF THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PUSHER WAS NOT ROTATED DURING THE PROCEDURE. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED. THE COIL WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359692 ↗